Delcath Systems Presents Positive Phase II Data on Delcath PHP System in Treatment of Inoperable Liver MetastasesNEW YORK--(BUSINESS WIRE)--Mar 31, 2008 - Delcath Systems, Inc. (NASDAQ: DCTH) today announced results from a study of the chemotherapy agent melphalan, delivered via the Company's Percutaneous Hepatic Perfusion (PHP) system, in patients with inoperable liver metastases from primary neuroendocrine tumors at the American Hepato Pancreato Biliary Association (AHPBA) 2008 Annual Meeting held March 27 to 30 in Ft. Lauderdale, Florida.
Patients with diffuse liver disease face limited treatment options and are often given very poor prognoses. The Delcath PHP System was designed to isolate blood flow from the liver, deliver very high doses of anti-cancer agent, then filter a majority of the agent out of the blood from the treated area. This process allows patients with large and diffuse liver tumors to receive a concentrated, site-specific treatment where resection, ablation, and embolization are not feasible or have failed to halt spread of the cancer.
In 24 patients who presented with diffuse liver metastases of pancreatic neuroendocrine and carcinoid tumors, a total of 68 treatments were administered. Of 19 evaluable patients, complete radiographic tumor responses were observed in 2 patients and partial responses were observed in 13 patients resulting in an objective tumor response rate of 79%. In addition, 1 minor response (21% tumor reduction with a duration of 43 months) was observed and only 1 of the 19 evaluable patients showed disease progression on therapy. Median overall survival, based upon an intention to treat analysis, was 40 months and median hepatic progression free survival for treated patients was 39 months. This update of the Phase II neuroendocrine trial data confirms the durable impact upon hepatic progression free survival and overall survival previously reported.
Findings were presented in an oral session by lead author Dr. James Pingpank Jr., MD. of the Surgery Branch of the NCI at the National Institute of Health in Bethesda, MD. "Treatment options for patients with diffuse hepatic disease are very limited," commented Dr. Pingpank. "The Delcath PHP System is unique in its ability to isolate then repeatedly treat unresectable liver tumors with high doses of anti-cancer agents such as Melphalan. This study shows that PHP with melphalan has efficacy in patients with diffuse metastatic neuroendocrine tumors of the liver that are too extensive for resection, ablation, or embolization. Responses to therapy tend to be durable, and repeat therapy is effective on progression or recurrence of disease. We look forward to further study of the PHP System and to understanding its full potential in treating patients with liver metastases."
Delcath plans to submit a new trial protocol to the FDA seeking to establish the use of PHP as a first line treatment of metastatic neuroendocrine tumors.
For more information about this and other studies of the Delcath PHP System in primary and secondary liver cancers, please visit www.livercancertrials.com.
About Delcath Systems, Inc.
Delcath Systems is a developmental stage company testing its percutaneous perfusion technology for the isolated delivery of high doses of therapeutic and chemotherapeutic agents. The Delcath System is currently being tested with the drug melphalan in Phase III and Phase II clinical trials. The Company's intellectual property portfolio currently consists of twenty-eight patents on a worldwide basis including the U.S., Europe, Asia and Canada. For more information, please visit the Company's website at www.delcath.com.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to our ability to successfully complete Phase III clinical trials and secure regulatory approval of our current or future drug-delivery system and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
Posted: March 2008